S0102: Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Listed as NCT00015938, this PHASE2 trial focuses on Breast Cancer and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 8 times since 2001, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)OBJECTIVES:
* Determine the 1-year survival of women with HER-2-negative stage IV breast cancer treated with docetaxel, vinorelbine, and filgrastim (G-CSF).
* Determine the response rate (both complete and partial response) and time to progression in patients treated with this regimen.
* Determine the qualitative and quantitative toxic effects of this regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1, vinorelbine IV over 6-10 minutes on days 8 and 15, and filgrastim (G-CSF) subcutaneously on days 2-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 4-5 months.
OBJECTIVES:
* Determine the 1-year survival of women with HER-2-negative stage IV breast cancer treated with docetaxel, vinorelbine, and filgrastim (G-CSF). * Determine the response rate (both complete and partial response) and time to progression in patients treated with this regimen. * Determine the qualitative and quantitative toxic effects of this regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1, vinorelbine IV over 6-10 minutes on days 8 and 15, and filgrastim (G-CSF) subcutaneously on days 2-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 4-5 months.
Status Flow
Change History
8 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
May 2023 — Jul 2024 [monthly]
Completed PHASE2
-
Jan 2021 — May 2023 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
May 2001
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Cancer Institute (NCI)
- SWOG Cancer Research Network
For direct contact, visit the study record on ClinicalTrials.gov .